Clinical and pharmacological group: & nbsp

Coagulants (including clotting factors), hemostatics

Included in the formulation
  • Octofactor
    lyophilizate in / in 
    GENERIUM, CJSC     Russia
  • Refacto AF
    lyophilizate in / in 
    Pfizer Inc.     USA
  • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    7 nosologies

    АТХ:

    B.02.B.D.02   Coagulation factor VIII

    Pharmacodynamics:

    The drug is a recombinant antihemophilic factor, the sequence of which corresponds to the form 90 + 80 kDa VIII factor of coagulability of blood. Increases the activity of clotting factor VIII in plasma, has the ability to temporarily correct the corresponding clotting disorders.

    The activated clotting factor VIII acts as a cofactor to activate coagulation factor IX, which accelerates the formation of the coagulation factor X from coagulation factor X. The activated coagulation factor X converts prothrombin to thrombin, which then converts fibrinogen to fibrin, resulting in a fibrin clot.

    In patients suffering from hemophilia A, the activity of coagulation factor VIII is significantly reduced, therefore, replacement therapy is necessary.

    Pharmacokinetics:

    The half-life of the drug is 12 hours.

    Indications:

    Prevention and control of bleeding in patients with hemophilia A at the age of 18 and over.

    III.D65-D69.D66   Hereditary deficiency of factor VIII

    III.D65-D69.D68.4   Acquired Coagulation Factor Deficiency

    Contraindications:

    Hypersensitivity to mouse proteins, Chinese hamster, morococcus alfa.

    Carefully:

    There is no information.

    Pregnancy and lactation:

    Taking the drug during pregnancy and lactation is possible only if there are strong indications.

    Dosing and Administration:

    Intravenously as an infusion, the dose is calculated individually according to a special formula that takes into account the patient's body weight and the desired final level of the blood clotting factor VIII.

    For short-term planned prophylaxis to reduce the incidence of spontaneous musculoskeletal bleeding in patients with hemophilia A morococcus alfa should be entered at least 2 times a week.

    Side effects:

    From the circulatory system: bleeding, vasodilation, arterial hypotension.

    From the nervous system and sensory organs: drowsiness, dizziness, a taste disorder.

    On the part of the urinary system: infection.

    From the respiratory system: rhinitis, dyspnoea.

    From the musculoskeletal system: increased activity of creatine kinase, arthralgia.

    From the immune system: the appearance of antibodies / inhibitors to the factor of blood coagulability VIII, the appearance of antibodies to murine IgG, cells of the Chinese hamster ovary.

    On the part of the digestive system: increased activity of hepatic transaminases, vomiting, nausea, diarrhea, anorexia, gastrointestinal bleeding, increased bilirubin content in the blood.

    Other: abdominal pain, pain at the injection site, fever, pain, catheter thrombosis, catheter loss, catheter infection, infections at the injection site, lethargy, fever, chills, headache.

    Overdose:

    Not described.

    Interaction:

    Not described.

    Special instructions:

    Treatment should be carried out exclusively under the supervision of a doctor who has experience in the treatment of hemophilia A. Also, careful monitoring of blood coagulability is necessary. Since the drug is a recombinant protein, it is necessary to have at hand means for arresting an attack of allergy. The drug should be discontinued if side effects occur.

    Instructions
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